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双氯芬酸钾CAMBIA（benzeneacetic酸衍生物）

2011-04-21 14:24:46 作者：新特药房来源：中国新特药网天津分站浏览次数：147 文字大小：【大】【中】【小】

简介： 制造商：鹦鹉螺神经科学公司药理分类：类固醇消炎药（benzeneacetic酸衍生物）活性成分（补）：双氯芬酸钾50毫克，每包;缓冲密码口服溶液，茴香，薄荷味;含有苯丙氨酸25mg/packet。指示（补） ...

制造商：
鹦鹉螺神经科学公司

药理分类：
类固醇消炎药（benzeneacetic酸衍生物）

活性成分（补）：
双氯芬酸钾50毫克，每包;缓冲密码口服溶液，茴香，薄荷味;含有苯丙氨酸25mg/packet。
指示（补）：
治疗急性或无先兆偏头痛。

药理作用：
双氯芬酸钾是一种benzeneacetic酸衍生物的非甾体抗炎药具有镇痛，消炎，解热和属性（类固醇消炎药）。它被认为是产生偏头痛通过抑制前列腺素合成酶治疗急性胰腺炎的影响。

临床试验：
两项随机，双盲，安慰剂对照试验进行评估Cambia疗效。这些研究招收年龄18-65岁的女性患者主要是白人。患者指示治疗中度至重度疼痛偏头痛与一剂或安慰剂或Cambia和评价其头痛痛两小时后的剂量。恶心，畏光，与声音恐惧症进行了评价。此外，患者的比例谁是“持续的疼痛”，作为一个中度或重度疼痛减轻头痛的严重程度在两个小时后，剂量无痛苦无轻度，中度或重度疼痛的回报，也没有使用定义抢救治疗后24小时内服药，还评价。

在这两个研究1和2，谁取得的患者治疗后两小时（24％和25比13％和10％，分别为％）和2-24小时后剂量（22％，持续疼痛疼痛自由自由的百分比19与10％和7％，分别为％）显着的患者相比，谁收到Cambia安慰剂更大。实现两个小时的治疗后疼痛缓解患者的比例也显着提高患者谁收到Cambia与那些谁收到（相对于27％和41％，分别为48％和65％）安慰剂。一个恶心，畏光和声音恐惧发生率降低在与Cambia安慰剂治疗相比，还表现。

法律分类：
接收

成人：
≥18yrs：以一个空的胃;将1包，30水60毫升（50毫克），只有立即饮用。使用最低有效剂量，最短时间。不具有生物等效性的双氯芬酸的其他形式。

儿童：
“18yrs：不推荐。

禁忌（补）：
阿司匹林过敏。冠状动脉搭桥手术。

警告/注意事项：
不被用作预防性治疗。心血管疾病。历史溃疡病或胃肠出血。高血压，监测血压。瑞士法郎。水肿。肝功能不全。晚期肾疾病：不推荐。监测血液，肝和肾功能的长期使用。出血性疾病。哮喘。脱水。老人。虚弱。妊娠（Cat.C：妊娠<30个星期; Cat.D：≥三零个星期妊娠，避免）。哺乳母亲：不推荐。

互动（补）：
避免使用阿司匹林。胃肠道出血的风险增加口服类固醇，抗凝血剂（显示器），酒精，吸烟。可拮抗利尿剂，血管紧张素转换酶抑制剂。监控与锂，甲氨蝶呤，环孢素毒性。可能受CYP2C9的抑制剂。注意与其他肝毒性药物（如对乙酰氨基酚，某些抗生素，抗癫痫药物）。避免使用非处方对乙酰氨基酚含产品。

不良反应（补）：
恶心，头晕，皮疹（可能是严重的，例如，史蒂文斯- Johnson综合征;停止，如果发生），增加出汗，胃肠道溃疡/出血，肝酶升高（如肝停止开发），血液恶液质，肾乳头坏死，过敏性反应。见文献回复：心血管事件的风险。

如何提供：
包- 1，9

最后更新：
2010年6月3日

Manufacturer:

Nautilus Neurosciences, Inc.

Pharmacological Class:

NSAID (benzeneacetic acid derivative)

Active Ingredient(s):

Diclofenac potassium 50mg; per packet; buffered pwd for oral soln; anise and mint flavor; contains phenylalanine 25mg/packet.

Indication(s):

Acute treatment of migraine with or without aura.

Pharmacology:

Diclofenac potassium is a benzeneacetic acid derivative non-steroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory, and antipyretic properties. It is thought to exert its effects in the acute treatment of migraine through prostaglandin synthetase inhibition.

Clinical Trials:

Two randomized, double-blind, placebo-controlled trials were conducted to assess the efficacy of Cambia. The studies enrolled predominantly white female patients aged 18–65 years. Patients were instructed to treat a migraine of moderate to severe pain with one dose of either Cambia or placebo and to evaluate their headache pain two hours post-dose. Associated symptoms of nausea, photophobia, and phonophobia were also evaluated. In addition, the proportion of patients who were “sustained pain free”, defined as a reduction in headache severity from moderate or severe pain to no pain at two hours post-dose without a return of mild, moderate, or severe pain and no use of rescue medication for 24 hours after treatment, was also evaluated.

In both Studies 1 and 2, the percentage of patients who achieved pain freedom two hours after treatment (24% and 25% versus 13% and 10%, respectively) and sustained pain freedom from 2–24 hours post-dose (22% and 19% versus 10% and 7%, respectively) was significantly greater in patients who received Cambia compared to placebo. The percentage of patients achieving pain relief two hours after treatment was also significantly greater in patients who received Cambia compared with those who received placebo (48% and 65% versus 27% and 41%, respectively). A decreased incidence of nausea, photophobia and phonophobia following treatment with Cambia compared to placebo, was also demonstrated.

Legal Classification:

Adults:

≥18yrs: Take on an empty stomach; mix 1 packet (50mg) with 30–60mL of water only and drink immediately. Use lowest effective dose for the shortest duration. Not bioequivalent to other forms of diclofenac.

Children:

<18yrs: not recommended.

Contraindication(s):

Aspirin allergy. Coronary artery bypass graft surgery.

Warnings/Precautions:

Not used as prophylactic therapy. Cardiovascular disease. History of ulcer disease or GI bleeding. Hypertension; monitor BP. CHF. Edema. Hepatic impairment. Advanced renal disease: not recommended. Monitor blood, hepatic, and renal function in long-term use. Bleeding disorders. Asthma. Dehydration. Elderly. Debilitated. Pregnancy (Cat.C: <30weeks gestation; Cat.D: ≥30weeks gestation; avoid). Nursing mothers: not recommended.

Interaction(s):

Avoid aspirin. Increased risk of GI bleed with oral corticosteroids, anticoagulants (monitor), alcohol, smoking. May antagonize diuretics, ACE inhibitors. Monitor for toxicity with lithium, methotrexate, cyclosporine. May be affected by CYP2C9 inhibitors. Caution with other hepatotoxic drugs (eg, acetaminophen, certain antibiotics, antiepileptics). Avoid nonprescription acetaminophen-containing products.

Adverse Reaction(s):

Nausea, dizziness, rash (may be serious, eg, Stevens-Johnson Syndrome; discontinue if occurs), increased sweating; GI ulcer/bleed, elevated liver enzymes (discontinue if hepatotoxicity develops), blood dyscrasias, renal papillary necrosis, anaphylactoid reactions. See literature re: risk of cardiovascular events.